Drugmaker Hetero said it has received World Health Organization (WHO) prequalification approval for its generic version of Pfizer’s Covid-19 oral antiviral treatment candidate nirmatrelvir.
“This is the first prequalification for a generic version of Pfizer’s Covid-19 oral antiviral drug ‘Paxlovid’, which the WHO called, the best therapeutic choice for high-risk patients to date,” a note from Hetero said.
Hetero’s combi-pack Nirmacom will contain nirmatrelvir 150 mg (2 tablets) and ritonavir 100mg (1 tablet). The cost to a patient for the entire course would be about ₹4,900, an industry-source said, adding that it would be sold only to hospital and government institutions, presently. It’s likely to be about cost $ 70 to a patient for the course, in low and middle income countries (LMIC), the sourced added. .
WHO made a strong recommendation for nirmatrelvir and ritonavir for mild and moderate Covid-19 patients at the highest risk of hospital admission, such as unvaccinated, aged or immunosuppressed patients.
In March, the Medicines Patent Pool had said it had signed agreements with 35 companies (including 19 from India) to make generic version of Pfizer’s paxlovid, at a reduced price for LMICs.
The product will be available by prescription and should be initiated as soon as possible after diagnosis of Covid-19 and within five days of symptom onset. Nirmacom will be manufactured at Hetero’s facilities in India, the company said.
Vamsi Krishna Bandi, Managing Director, Hetero Group of Companies, said, “WHO Prequalification for Nirmacom is a significant milestone in the fight against Covid-19 as it allows us to expand access to this important innovative antiretroviral drug to people in need. We are committed to making Nirmacom available faster at affordable prices across 95 LMICs including India.”
Charles Gore, Executive Director of MPP said, “We are delighted to see the first generic version of nirmatrelvir under MPP license with Pfizer, receive quality assurance approval from WHO. This is an impressive achievement from Hetero as we announced the sub-licence agreements just nine months ago. With cases of Covid-19 again on the rise we need to make treatments readily available in LMICs so no one is left behind.”
Hetero has already received Emergency Use Authorization (EUA) approval from the Drugs Controller General of India (DCGI) to manufacture and market Nirmacom. (eom)